A multicenter, open-label, long-term safety study of AR101 characterized oral desensitization immunotherapy in subjects who participated in a prior AR101 study - Long-term Safety Study of AR101 CODIT™

AIMMUNE THERAPEUTICS0 sites1,100 target enrollmentFebruary 12, 2019

Overview

No summary available.

Registry

who.int

Start Date

February 12, 2019

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Subjects must meet all the following criteria to be eligible:
•1\. Prior participation in one of the following Aimmune AR101 clinical studies: ARC002, ARC004, ARC007, ARC010, ARC011, or any future
•clinical study that identifies ARC008 as a follow\-on study option in the protocol
•2\. Written informed consent from the subject or guardian/parent (or both parents where required by local authorities) in accordance with local institutional review board (IRB)/ethics committee (EC) guidelines
•3\. Written assent from the subject as required by local IRB/EC guidelines
•4\. Use of effective birth control by sexually active females of childbearing potential (Section 5\.9\.4\)
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 1
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 50

•Subjects who meet any of the following criteria are not eligible:
•1\. Did not complete a minimum of 3 months of AR101 Maintenance in the parent study if subject was assigned to AR101 in that study, except for
•subjects in ARC004 who did not tolerate the nondaily AR101 dosing regimen, subjects in ARC007, or unless specified otherwise in the parent study
•2\. For subjects treated with AR101 in the parent study requiring a food challenge, failure to successfully consume at least the 300 mg single dose (443 mg cumulative dose) of peanut protein at parent study's exit food challenge
•3\. History of chronic disease (other than asthma, atopic dermatitis, or allergic rhinitis) that is, or is at significant risk of, becoming unstable or
•requiring a change in chronic therapeutic regimen, including malignancies occurring within 5 years prior to Screening and clinically active autoimmune diseases
•4\. Subjects with a history of alcohol, illicit or recreational drug or prescribed medication abuse
•5\. Developed a clinically significant change in health status during the parent study that, in the opinion of the investigator, would make the subject unsuitable for participation in this study
•6\. Taking a prohibited medication, as listed in Section 5\.9\.5
•7\. Currently participating in any other interventional clinical study other than the Aimmune parent study